ZYLAPINE ODT olanzapine 5 mg orally disintegrating tablet blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Prenos Javno poročilo o oceni (PAR)
16-05-2019

Aktivna sestavina:

olanzapine, Quantity: 5 mg

Dostopno od:

Arrotex Pharmaceuticals Pty Ltd

Farmacevtska oblika:

Tablet, orally disintegrating

Sestava:

Excipient Ingredients: microcrystalline cellulose; polacrilin potassium; aspartame; mannitol; crospovidone; sodium stearylfumarate; colloidal anhydrous silica; Flavour

Pot uporabe:

Oral

Enote v paketu:

7, 28

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

ZYLAPINE ODT is indicated for the treatment of schizophrenia and related psychoses. ZYLAPINE ODT alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. ZYLAPINE ODT for preventing recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.

Povzetek izdelek:

Visual Identification: Yellow coloured, circular, flat faced beveled edge tablets debossed with 'C' on one side and '51' on the other side; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status dovoljenje:

Licence status A

Datum dovoljenje:

2017-11-03